Use of Cesarean Birth at Private Health Facilities in Lilongwe and Blantyre, Malawi

The purpose of the research study is to collect preliminary data to which future outcomes after implementing quality improvement projects or research will be compared. There will be observation of the labor and delivery services received and resulting outcomes of women and infants who deliver at private health facilities in urban Malawi. Data will be collected at admission, delivery, and discharge from women and providers on patient characteristics, labor and obstetric characteristics, delivery factors, and pregnancy outcomes that result during the course of the hospitalization. This will include the vital status of the mother and the infant. The overall hypothesis is that cesarean birth rates will be higher than the ecologically supported 10% cesarean birth rate, and that there may be cesareans that are performed without clear medical indication.

Study Overview

• Status: Completed
• Conditions: Cesarean Section

Detailed Description

Background:

Cesarean birth is the most commonly performed surgery in the world. It is a major abdominal procedure that can save maternal and perinatal lives when properly indicated, but when performed without medical necessity, is associated with adverse outcomes. Global cesarean birth rates are increasing, but there has been a less pronounced rise in sub-Saharan Africa (SSA) where rates tend to be below 5.0%. However, in Sub-Saharan Africa (SSA) and other low- and middle-income countries (LMIC), there is a recognition that significant in-country disparities in the use of cesarean birth exist. Rates are higher in urban settings, and there is evidence that they are higher in private versus public facilities.

Objective and Aims:

The main objective of this prospective, cross-sectional, observational study is to observe the use of cesarean birth at three private health facilities in urban Malawi by the end of the study. This will be achieved by getting an understanding of the current delivery practices and patient characteristics, as well as associated outcomes of women who choose to deliver at these private facilities in order to understand how and under what circumstances the surgery is being used.

Aim 1: Observe prevalence of and indications for cesarean birth in three private health facilities in urban Malawi in the overall cohort and in ten mutually exclusive subgroups defined by the WHO-endorsed Robson Classification for cesarean birth

Aim 2: Determine risk factors associated with cesarean birth among Robson subpopulations of women at study sites, and the distribution of adverse pregnancy outcomes across those subgroups

Aim 3: Identify target modifiable risk factors or areas for potential quality improvement or prospective research studies to optimize the use of cesarean birth within these facilities that may have generalizable implications

• Study Type: Observational
• Enrollment (Actual): 260

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • Mwaiwathu Private Hospital
  • Lilongwe, Malawi
    • Area 18 Medi Clinic - Asamala Health Services
  • Lilongwe, Malawi
    • Good Hope Private Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All pregnant women admitted for observation or delivery at 3 private health facilities in Malawi.

Description

Inclusion Criteria:

• Pregnancy
• Admitted for delivery or observation

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of participants using cesarean section delivery as assessed by survey questionnaires	Hospital admission to discharge, about 3-4 days
Types of indications for cesarean birth	Hospital admission to discharge, about 3-4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types of adverse pregnancy outcomes among participants using cesarean section	The types of adverse pregnancy outcomes reported among participants with cesarean section deliveries will be assessed via survey questionnaires. Data will be reported by population subgroup. Population subgroups will be defined by the World Health Organization-endorsed Robson Classification for Cesarean Birth	Hospital admission to discharge, up to 1 week
Types of risk factors for Cesarean birth	The types of modifiable risk factors for cesarean birth reported among participants that use cesarean section delivery will be assessed via survey questionnaires	Hospital admission to discharge, about 3-4 days

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Margo Harrison, MD, MPH, University of Colorado - Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2022
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (ACTUAL): June 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cesarean section; Cesarean birth
• Other Study ID Numbers: 20-0468; NICHD/K12 HD001271-21 (OTHER_GRANT: NICHD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No